The following data is part of a premarket notification filed by J. Jamner Surgical Instruments, Inc. with the FDA for Jarit Hulka Uterine Tenaculum Forceps.
| Device ID | K082349 |
| 510k Number | K082349 |
| Device Name: | JARIT HULKA UTERINE TENACULUM FORCEPS |
| Classification | Tenaculum, Uterine |
| Applicant | J. JAMNER SURGICAL INSTRUMENTS, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Jennifer Bosley |
| Correspondent | Jennifer Bosley J. JAMNER SURGICAL INSTRUMENTS, INC. 589 DAVIES DRIVE York, PA 17402 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-15 |
| Decision Date | 2008-11-21 |
| Summary: | summary |